Overview

Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Akros Pharma Inc.
Criteria
Inclusion Criteria:

- Subjects who have ESRD and have been receiving maintenance hemodialysis for at least
12 weeks prior to the Screening Visit

- Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between
20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit

- Hemoglobin value as defined in the protocol

- Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening
Visit as defined in the protocol

Exclusion Criteria:

- Transferrin saturation and ferritin levels at the Screening Visit as defined in the
protocol

- Anemia due to known causes other than chronic kidney disease

- Known history of hyporesponsiveness to ESAs

- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening
visit